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Seagen
Manager Regulatory CMC
Development - Zug, Switzerland
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary
The Manager, Regulatory CMC supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position represents Regulatory CMC on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities.
Responsibilities:
- Provide regulatory representation at cross-functional and partner team meetings, including tactical support and timelines
- Communicate regulatory policy to product development teams and provide clarity on regulatory expectations and timelines
- Prepare, maintain and/or coordinate global regulatory submissions (INDs, CTAs, marketing applications) in accordance with applicable regulations
- Assist in preparation for regulatory authority interactions and participate in regulatory authority meetings
- May function as primary liaison with regulatory authorities for routine communications in support of submissions for commercial products
- Work with partners and contract research organizations for ex-US regulatory submissions
Qualifications:
- Biotechnology experience preferred
- Solid knowledge and understanding of the drug development process and regional regulatory requirements
- Experience in the preparation/submission of regulatory documentation to support regulatory submissions
- Excellent oral and written communication skills
- Strong technical/analytical skills to identify and solve problems independently
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Willingness to work collaboratively
- Self-motivated, assertive, and self-confident
- Strong organizational skills to maintain a high level of productivity, prioritize work and coordinate work done by matrixed teams
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
- Proactively seeks out innovations for regulatory submissions and recommends process improvements
- Enjoys working in a fast-paced environment
- Thorough understanding of local compliance, as well as a sound ethical approach to business
Education:
- BSc and +5 years regulatory experience; advanced degree (MSc, PhD, PharmD) and +2 years desirable
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 04/08/2022
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